Payments help bear cost of reviewing brand-name and generic drugs and other medical products

A bipartisan bill in Congress calls for sharp increases in user fees paid by medical industries to the Food and Drug Administration to bear the cost of reviewing brand-name and generic drugs, medical devices and a type of generics called biosimilars.

The total base fees for prescription drugs to be collected for fiscal year 2018 under the legislation would be about $878.8 million, up 22% from this fiscal year’s amount of $718.7 million, according to congressional aides.

The payments from industry have previously accounted for 70% of the FDA’s brand-name drug review budget, 36% of the medical device review budget, 75% of the budget for generic drug reviews and 29% of that for biosimilars, which mimic complex biological drugs. Industry fees for medical products total about $1.3 billion in the current FDA budget of about $4.8 billion.

Every five years, Congress reauthorizes the payments of user fees, which are designed to speed drug approvals without unduly burdening U.S. taxpayers. Whether they do that appropriately, or give the medical industry excessive entree into the FDA, has been hotly debated for years.

This year happens to call for a new five-year bill. So far, the draft bill made public by the leadership of both parties has been relatively lacking in controversy, but that could change.

The dollar amounts in the bill were negotiated by the FDA with the industries involved. But the issue got more complicated last month when the Trump administration said it planned to nearly double, to more than $2 billion, the user fees collected from the medical industry. Congressional staffers said it would be difficult to comply with the administration’s request, since negotiations are already completed.